Japan Releases Notification No. 108, Bringing About a Revolution in the Functional Food Industry, Effective September 1st!

On August 30, 2024, the Cabinet Office of Japan issued a notice No. 108, establishing the production and processing standards for functional foods in specific forms, which involve naturally extracted ingredients. The move is intended to strengthen the supervision of similar food products after the damage incident of Kobayashi Pharmaceutical's red yeast products.

The announcement details the definition and terminology, applicable product scope (including lozenges, capsules and other specific forms of functional foods containing natural extracted ingredients), production and processing enterprises qualification management, personnel and quality management system requirements, enterprise requirements for the safety verification of natural extracted ingredients in functional foods, production process hygiene control requirements, functional foods Inspection regulations, traceability and management of production and sales records, verification requirements after major changes in production technology and production environment, and reporting procedures after adverse reactions occur.

The effective date of the announcement is set for September 1, 2024.